FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
42806-410
11-digit product format
428060410
Labeler code
42806
Product ID
42806-410_af1a3522-8180-4e3f-a2fc-c9fe143997a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma LLC
Application
ANDA075932
Marketing category
ANDA
Marketing start
2021-12-15
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075932-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25
A075932-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22
A075932-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075932-001AB1
A075932-002AB1
A075932-003AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12004-03-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12005-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075932-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12003-11-258072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075932-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075932-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075932-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075932-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075932-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075932-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075932-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075932-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075932-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075932-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075932-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075932-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075932-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075932-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075932-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075932-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075932-001AB118072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEEpic Pharma LLC9fb44e96-6160-4a4a-90cb-91764c0dcd892024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075932
application number: ANDA075932
ndc (product): 42806-410
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutions87dac2ee-732c-465b-8ffe-e5aeba4214252024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075932
application number: ANDA075932

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZG7E5POY8OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993503Internal RxNorm lookup
993518Internal RxNorm lookup
993536Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fb44e96-6160-4a4a-90cb-91764c0dcd89Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-410-01BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
42806-410-05BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
42806-410-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-410-01EA - Each42806-410b9cf194a-fb98-4717-9e80-9f80a0d4b84d12022-01-06
42806-410-05EA - Each42806-410a69b3cdd-097f-4fe0-8aa2-2c5c581283d212022-01-06
42806-410-60EA - Each42806-410208e4c23-0d30-431d-b325-9d33ccef9c5b12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-410BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EPIC PHARMA LLC]4Current NDC, Legacy NDC, 3 package rows20231221_9fb44e96-6160-4a4a-90cb-91764c0dcd89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN9fb44e96-6160-4a4a-90cb-91764c0dcd895
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN9fb44e96-6160-4a4a-90cb-91764c0dcd895
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN9fb44e96-6160-4a4a-90cb-91764c0dcd895
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD9fb44e96-6160-4a4a-90cb-91764c0dcd895
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9fb44e96-6160-4a4a-90cb-91764c0dcd895
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD9fb44e96-6160-4a4a-90cb-91764c0dcd895
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY9fb44e96-6160-4a4a-90cb-91764c0dcd895
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY9fb44e96-6160-4a4a-90cb-91764c0dcd895
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY9fb44e96-6160-4a4a-90cb-91764c0dcd895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-410-0142806041001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-410-01) 2021-12-150000-00-00NoNoCurrent
42806-410-0542806041005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-410-05) 2021-12-150000-00-00NoNoCurrent
42806-410-604280604106060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-410-60) 2021-12-150000-00-00NoNoCurrent